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Effect of remimazolam tosylate on postoperative delirium after urological surgery in elderly patients

Effect of remimazolam tosylate on postoperative delirium after urological surgery in elderly patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088406
Enrollment
Unknown
Registered
2024-08-19
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative delirium

Interventions

Remimazolam tosylate group (group R):Remimazolam tosylate is induced at 0.2-0.3 mg/kg and maintained at 0.5-1.2 mg/(kg·h).
Propofol group (group P):Propofol is induced at 1.0-1.5 mg/kg and maintained at 2-10 mg/(kg·h).

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Urological surgery under general anesthesia 2. Age 65 years old and above 3. ASA grading I-III 4. Body mass index (BMI) 18-28 kg/m2

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Those who are unable to communicate in speech due to deafness or muteness 3. Central nervous system disease (cerebral hemorrhage, cerebral infarction) or psychiatric disease, preoperative dementia, memory or cognitive dysfunction 4. Other conditions, including intolerance or allergy to benzodiazepines, long-term preoperative use of benzodiazepines or opioid analgesics, myasthenia gravis, schizophrenia and severe depressive state, preoperative sleep disturbance 5. Severe cardiopulmonary disease (including moderate to severe valvular heart disease, second- or third-degree atrioventricular block, moderate to severe decline in lung function) 6. The duration of the operation= 4 hours or the duration of the operation<1 hour 7. Intraoperative blood loss= 600ml or hemoglobin <80g/L 8. Those who are admitted to the recovery room after surgery and do not plan to be intubated again 9. Admission to ICU after surgery 10. During the course of the study, the trial needs to be terminated due to serious adverse reactions

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative delirium;

Secondary

MeasureTime frame
Time from the end of the operation to extubation;Intraoperative hemodynamic changes;QoR-15 score within 24 hours after surgery;Hemoglobin concentration at suture;Perioperative propofol/remimazolam tosylate, remifentanil consumption;Intraoperative vasoactive drug use;Intraoperative fluid volume;Intraoperative fluid output;Consumption of salvage analgesic drugs within 24 postoperative periods;Length of hospital stay after surgery;Adverse reaction rate;

Countries

China

Contacts

Public ContactGuanglei Wang

The Affiliated Hospital of Xuzhou Medical University

wguanglei2000@163.com+86 138 5208 7156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026